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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. India’s central drug regulator, CDSCO has requested state drug regulators to direct manufacturers of Carbimazole formulations to incorporate agranulocytosis as an adverse drug reaction in Prescribing Information Leaflets (PIL) following recommendation by the Subject Expert Committee on Endocrinology and Metabolism.
Source: short-url.org/1pcz1

2. The Central Pollution Control Board (CPCB) has introduced a Common EPR Portal to unify all Extended Producer Responsibility activities under one platform. Through Single Sign-On (SSO), users can access Plastic, E-Waste, Battery, Tyre and Used Oil Management portals, and the EPR Trading Platform with one login. Registration is mandatory, with no additional fee.
Source: short-url.org/1pcz4

3. The Madras High Court has reportedly strongly criticised the practice of imposing non-compete and non-solicitation clauses on doctors in employment contracts, calling such restrictive covenants “unlawful on the face of it” and questioning their enforceability in healthcare settings. The bench indicated it will discourage hospitals from using these clauses, emphasising doctors’ freedom to practice and patient choice.
Source: short-url.org/1pcz6

4. The National Pharmaceutical Pricing Authority has reportedly deferred a decision on creating a separate price ceiling for cementless knee implants. The Multidisciplinary Committee will invite subject experts and manufacturers for detailed deliberations. Until a final determination is made, all companies must continue complying with the existing ceiling prices.
Source: short-url.org/1k7in

5. India’s drug regulator CDSCO is enhancing the online WHO-GMP Certificate of Pharmaceutical Product (CoPP) application via its ONDLS portal, partnering with C-DAC and state authorities to replace manual submissions. The digital shift aims to cut delays, improve transparency, and boost export readiness for Indian pharma manufacturers.
Source: short-url.org/1pcze

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. India’s central drug authority has released guidance to identify spurious drugs under the Drugs Rules, 1945. Earlier, the rules mandated QR codes on all APIs from January 2023 and barcodes or QR codes on the top 300 drug brands from August 2023. The authority has now issued a process flow to verify drug authenticity.
Source : https://short-url.org/1gVQq

2. India’s Central Drug Regulator has allowed manufacturers to apply for Certificate of Pharmaceutical Product/World Health Organization – Good Manufacturing Practices (COPP/WHO-GMP) certificates while product license applications are under review by the State Licensing Authority. Final COPP/WHO-GMP certificate will be issued after product approval.
Source: https://short-url.org/1gVUB

3. India’s central government has proposed the Assistive Technology (Standards and Accessibility) Rules, 2025, requiring all assistive devices to meet Bureau of Indian Standards quality standards. The draft ensures transparent procurement, financial aid, repair support, and a toll-free helpline, with an online Assistive Technology Portal for device certification, supply tracking, and grievance redressal.
Source: https://short-url.org/1ceKb

4. The Food Safety and Standards Authority of India has kept the spice enforcement drive (whole & powder) in abeyance until further orders. All state food safety commissioners and regional directors have been instructed not to initiate any action under the earlier directive until further instructions.
Source:
https://short-url.org/1ceKS
https://short-url.org/1gVSp

5. The US Food and Drug Administration (FDA) is seeking public input on evaluating AI-enabled medical devices, including generative AI tools. The aim is to enhance patient outcomes, public health, and accelerate medical innovation, while regulating these advanced technologies
Source: https://short-url.org/1ceLs

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. The Delhi government’s ban on sending genetic samples outside the city for prenatal tests like NIPT and PGT, reportedly, faces strong opposition from diagnostic labs in Delhi. The labs have raised concerns that it will overload local labs, cause delays, increase costs, and limit access for patients in NCR and nearby states, urging reconsideration of the directive.
Source: short-url.org/1gmX1

2. The Bombay High Court has in a customs case held that allowing re-testing of seized goods is a trade facilitation measure. Denials must be rare and when made should be supported by written reasons. The court emphasized that refusal to retest should not be the norm.
Source: short-url.org/1gmXa

3. The Indian government will reportedly require all hospitals, both public and private, to include an Adverse Drug Reaction reporting form in every patient admission record. This under the Pharmacovigilance Programme of India aims to standardise monitoring of drug safety and better protect patients from adverse effects.
Source: short-url.org/1bHWo

4. The Committee for Control and Supervision of Experiments on Animals (CCSEA) has clarified that beagle dogs procured from breeders registered with State Animal Welfare Boards or State Animal Husbandry Departments are strictly for breeding colonies, not for experimentation. For testing, dogs must be sourced from CCSEA registered establishments.
Source: short-url.org/1bHWu

5. To ease certificate issuance delays, India’s central drug licensing authority reportedly has plans of shifting data verification in the CoPP (Certificate of Pharmaceutical Product) process to later stages instead of initial stage and conduct verification themselves bypassing initial scrutiny by state regulators.
Source: short-url.org/1gmXq